Low profile stent graft and delivery system

ABSTRACT

A tubular prosthetic device for implantation into a body lumen includes a first part including a tubular lumen and a second part including an attachment member. The second part is secured to the first part via various configurations, where the device is capable of being reduced to a diameter less than the diameter of traditional devices, for ease of use during implantation. Methods of using the device are also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/263,469, filed Sep. 13, 2016, which is a continuation of U.S. patentapplication Ser. No. 14/923,477, filed Oct. 27, 2015, now U.S. Pat. No.9,463,101, granted Oct. 11, 2016, which is a continuation of U.S. patentapplication Ser. No. 13/803,037, filed Mar. 14, 2013, now U.S. Pat. No.9,192,462, granted Nov. 24, 2015, which claims the benefit of U.S.Provisional Application No. 61/621,038, filed Apr. 6, 2012, the contentsof all of which are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to a system for the treatment of disordersof the vasculature. Specifically, the invention relates to implantablegrafts having a low profile attachment means.

BACKGROUND

The present invention relates to a system for the treatment of disordersof the vasculature, particularly aneurysms. An aneurysm is a medicalcondition indicated generally by an expansion and weakening of the wallof an artery of a patient. Aneurysms can develop at various sites withina patient's body. Thoracic aortic aneurysms (TAAs) or abdominal aorticaneurysms (AAAs) are manifested by an expansion and weakening of theaorta which is a serious and life threatening condition for whichintervention is generally indicated. Existing methods of treatinganeurysms include invasive surgical procedures with graft replacement ofthe affected vessel or body lumen or reinforcement of the vessel with agraft.

Surgical procedures to treat aneurysms can have relatively highmorbidity and mortality rates due to the risk factors inherent tosurgical repair of this disease, as well as long hospital stays andpainful recoveries. Due to the inherent risks and complexities ofsurgical repair of aortic aneurysms, endovascular repair has become awidely used alternative therapy, most notably in treating AAAs. Earlywork in this field is exemplified by Lawrence, Jr. et al. in“Percutaneous Endovascular Graft: Experimental Evaluation”, Radiology(May 1987) and by Mirich et al. in “Percutaneously Placed EndovascularGrafts for Aortic Aneurysms: Feasibility Study,” Radiology (March 1989).Commercially available endoprostheses for the endovascular treatment ofAAAs include the Endurant® stent graft system manufactured by Medtronic,Inc. of Minneapolis, Minn., the Zenith® stent graft system sold by Cook,Inc. of Bloomington, Ind., the PowerLink® stent graft systemmanufactured by Endologix, Inc. of Irvine, Calif., and the Excluder®stent graft system manufactured by W.L. Gore & Associates, Inc. ofNewark, Del. A commercially available stent graft for the treatment ofTAAs is the TAG™ system manufactured by W.L. Gore & Associates, Inc.

When deploying such endovascular devices by catheter or other suitableinstrument, it is advantageous to have a flexible and low profile stentgraft and delivery system for passage through the various guidingcatheters as well as the patient's sometimes tortuous anatomy. Many ofthe existing endovascular devices and methods for treatment ofaneurysms, while representing significant advancement over previousdevices and methods, use systems having relatively large transverseprofiles, often up to 24 French. The profile of stent grafts may beimportant to achieve a favorable clinical result.

Traditional stent graft systems incorporate a full metal ring at one endof the graft, to which a stent may be attached. Although this providessecurement of the stent to the graft end, it is difficult to compressthe stent graft to a small size for delivery. What has been needed arestent graft systems and methods that are capable of being compressed toa small size and can be safely and reliably deployed using a flexiblelow profile system.

SUMMARY OF THE INVENTION

In one embodiment of the present invention, there is provided a devicefor implantation into a body lumen having a reduced implantationdiameter, including: (a) a generally tubular first part having a lumenextending therethrough for the flow of bodily fluid, the first partincluding a first open end and a second open end; and (b) a second partattached to the first open end of the first part, where the second partis capable of securing the device into a body lumen; where the firstopen end includes an attachment flap that is compressible to a reduceddiameter as compared to a device incorporating a full attachment ring,and where the attachment flap includes a plurality of attachment sitessecured by a plurality of attachment tethers.

In another embodiment, there is provided a method of implanting atubular prosthesis into a body lumen of a patient, including the stepsof: (a) providing a device for implantation into a body lumen having areduced implantation diameter, including: (i) a generally tubular firstpart having a lumen extending therethrough for the flow of bodily fluid,the first part including a first open end and a second open end; and(ii) a second part attached to the first open end of the first part,where the second part is capable of securing the device into a bodylumen; where the first open end includes an attachment flap that iscompressible to a reduced diameter as compared to a device incorporatinga full attachment ring, and where the attachment flap includes aplurality of attachment sites secured by a plurality of attachmenttethers.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a representative embodiment of traditional stent attachmentsystems.

FIG. 2 is a representation of one embodiment of the inventionincorporating a reduced size attachment flap design.

FIG. 3 is a representation of an alternative embodiment of the inventionincorporating a single point attachment of the stent to the graft.

FIG. 4 is a representation of an alternative embodiment of the inventionincluding a radially expandable ring and a single point attachment ofthe stent to the graft.

FIGS. 5A and 5B are each a representation of yet another embodiment ofthe invention including single point attachments of the stent to thegraft using a supported hole and optional tethered design.

FIG. 6A is a side view of yet another embodiment of the inventionincluding a single point attachment of the stent to the graft with asupporting roll feature.

FIG. 6B is a close up of the supporting roll feature of FIG. 6A.

FIG. 7 is a close up of yet another embodiment of the inventionincluding a single point attachment of the stent to the graft with areinforced hole feature.

FIGS. 8A and 8B depict an embodiment of the present invention includinga series of reinforcement tabs to secure a stent to a graft.

FIG. 9 depicts an embodiment of the present invention includingfolded-over graft material to secure a stent to a graft.

DETAILED DESCRIPTION OF THE INVENTION

Embodiments of the invention are directed generally to methods anddevices for treatment of fluid flow vessels with the body of a patient.In particular, the invention relates to devices designed forimplantation into a body vessel of a patient, which allow the flow offluid, such as blood, therethrough. Typical prosthetic devices include afirst part, which is a substantially tubular member through which fluidmay flow. The first part may be referred to as a graft, or a graft body.This first part is typically made of a biocompatible, substantiallyfluid tight material, and may include fabrics or polymers. For example,the first part may be made from materials includingpolytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene(ePTFE). In particular, this first part may include any number of layersof PTFE and/or ePTFE, including from about 2 to about 15 layers, havingan uncompressed layered thickness of about 0.003 inch to about 0.015inch. Unless otherwise specifically stated, the term “PTFE” as usedherein includes both PTFE and ePTFE. Furthermore, the graft bodysections of the present invention described herein may include all PTFE,all ePTFE, or a combination thereof. Such graft body sections mayinclude any alternative biocompatible materials, such as DACRON,suitable for graft applications. Useful materials include, but are notlimited, polyethylene; polypropylene; polyvinyl chloride;polytetrafluoroethylene; fluorinated ethylene propylene; fluorinatedethylene propylene; polyvinyl acetate; polystyrene; poly(ethyleneterephthalate); naphthalene dicarboxylate derivatives, such aspolyethylene naphthalate, polybutylene naphthalate, polytrimethylenenaphthalate and trimethylenediol naphthalate; polyurethane, polyurea;silicone rubbers; polyamides; polyimides; polycarbonates; polyaldehydes;polyether ether ketone; natural rubbers; polyester copolymers; silicone;styrene-butadiene copolymers; polyethers; such as fully or partiallyhalogenated polyethers; and copolymers and combinations thereof.

Particularly useful materials include porous polytetrafluoroethyleneeither with or without a discernable node and fibril microstructure and(wet) stretched PTFE layer having low or substantially no fluidpermeability that includes a closed cell microstructure having highdensity regions whose grain boundaries are directly interconnected tograin boundaries of adjacent high density regions and havingsubstantially no node and fibril microstructure, and porous PTFE havingno or substantially no fluid permeability. PTFE layers lacking distinct,parallel fibrils that interconnect adjacent nodes of ePTFE and have nodiscernable node and fibril microstructure when viewed at a scanningelectron microscope (SEM) magnification of 20,000.

A porous PTFE layer having no or substantially no fluid permeability mayhave a Gurley Number of greater than about 12 hours, or up to a GurleyNumber that is essentially infinite, or too high to measure, indicatingno measurable fluid permeability. Some PTFE layers having substantiallyno fluid permeability may have a Gurley Number at 100 cc of air ofgreater than about 1×10⁶ seconds. The Gurley Seconds is determined bymeasuring the time necessary for a given volume of air, typically, 25cc, 100 cc or 300 cc, to flow through a standard 1 square inch ofmaterial or film under a standard pressure, such as 12.4 cm column ofwater. Such testing maybe carried out with a Gurley Densometer, made byGurley Precision Instruments, Troy, N.Y.

Descriptions of various constructions of graft bodies may be found inU.S. Pat. No. 7,125,464 and entitled “Method for Manufacturing anEndovascular Graft Section”, the entire contents of which areincorporated herein by reference, and in U.S. Patent ApplicationPublication Nos. 2006/0233991, entitled “PTFE Layers and Methods ofManufacturing” and 2006/0233990, entitled “PTFE Layers and Methods ofManufacturing”, the contents of all of which are incorporated herein byreference.

The second part of such devices includes an attachment member, which maybe used to secure the device to the lumen into which the device is beingimplanted. The attachment member may be secured to one or more ends ofthe first part by means of a connector ring that is at least partiallydisposed in a wall portion of one or more ends of the first part, aswill be explained in further detail below. The attachment member may bein the form of an expandable member or stent. The attachment member maybe used to anchor one end of the first part (for example, the distal endor the proximal end) to the patient's vasculature. The first part mayinclude an optional first attachment element or ring, which may bedisposed adjacent one end of the first part and is configured to besecurable to the attachment member to the first part. The attachmentmember and attachment ring, for example, may be configured as any of theattachment elements in U.S. Patent Application Publication No. US2005/0228484 A1, which is hereby incorporated by reference herein in itsentirety.

In one embodiment, the second part may include a tubular stent, whichjoins the first part to the lumen into which it is implanted. The stentmay be self-expanding or may be expandable upon force, such as through aballoon. The stent may also optionally include barbs that are angledoutwardly from the attachment member and are configured to engage tissueof the vessel wall of the patient, and prevent axial movement of thedevice once deployed. In use, the device is typically implanted into thelumen and held in place, at which time the stent is expanded to securethe device to the inside of the body lumen, allowing flow of fluidtherethrough. Stent attachment means are particularly useful becausestents allow for quick, accurate and safe implantation, while avoidingthe need to suture or otherwise surgically secure the device in place. Astent attachment member is typically secured to the first part by meansof an attachment ring, which spans the circumference of the first partand secures the stent to the first part. However, the present inventionprovides devices in which the second part, including attachment member,may be secured to the first part without the need for a typicalattachment ring.

Devices such as that disclosed herein are typically implanted into thepatient's body through the use of a catheter or other implantationdevice, which travels through the body lumen and allows deployment ofthe device therein. As will be understood to those of ordinary skill inthe art, since the deployment of the device is conducted through thebody vessel, the device must typically be compressed or rolled such thatit has a small diameter. Prior art devices have typically only been ableto achieve a compressed thickness of 18-25 French. The presentinvention, however, has been able to achieve much smaller diameters in acompressed or rolled condition. The compressed or rolled diameter of thepresent invention is about 9 French to about 15 French, and morespecifically from about 11 French to about 14 French. The small diameterallows the device to travel through the body lumen safely andaccurately. Devices are typically rolled or compressed into a smalldiameter, placed into the catheter, and led through the vessel intoposition, where the catheter releases the device. Thus, a small diameteris important to success in implantation. However, when the device to beimplanted includes a securement device attached thereto, such as a stentmember, it is often difficult to achieve the small diameter desired forimplantation. This is particularly true when the first part of thedevice includes a full attachment ring, as depicted in FIG. 1.

FIG. 1 depicts a traditional device, including a first part secured to asecond part via a full attachment ring. As seen in FIG. 1, a traditionalimplantable device 10 includes a first part 20, which is a generallytubular member made of a fluid tight material or materials as discussedabove, and a second part 30, which is used to secure the device 10 tothe inside of a body lumen. In embodiments including such a separatesecond part 30, the second part 30 is typically a tubular stent member,which may be made from any number of materials, including polymericmaterials, metals, and combinations thereof. The second part 30 may bejoined to the first part via securement anchors 35, which may includeeyelets, hooks, holes, snaps, “dog-bone” configurations, andcombinations thereof.

As will be understood, of course, the use of a separate first part 20and second part 30 in these devices 10 requires a means to secure thefirst part 20 and the second part 30 to each other in such a manner thatthe two will not become separated either during the implantation processor after implantation is complete. To achieve this securement, thedevice 10 will oftentimes include an attachment ring 40, which isdisposed at one or more open ends of the first part 20, and whichtravels the entire circumference of the first part 20. The attachmentring 40 is typically a continuous ring of solid material, sometimeshaving a wave pattern, which spans the entire circumference of the firstpart 20. The attachment ring 40 is usually made of similar materials asthe second part 30, including solid metals and polymeric materials,which aid in providing a secure attachment of the first part 20 andsecond part 30. The attachment ring 40 is typically embedded in apolymeric region, located at one or more ends of the first part 20. Thesecond part 30 is secured to the attachment ring 40 via a plurality ofsecurement anchors 35, which may include eyelets, hooks, holes, snaps,“dog-bone” configurations, and combinations thereof.

As can be appreciated, the presence of a full attachment ring 40 at oneor more ends of the first part 20, spanning the entire circumference ofthe first part 20, renders the collapsing and compression of the device10 difficult to achieve. This is especially true when the attachmentring 40 is made of solid metal or polymeric materials, and has asignificant wave shape. Although such devices are somewhat capable ofbeing compressed to suitable sizes, it is often difficult and cumbersometo deploy such devices in a safe and economic manner. The presentinvention is directed to devices which include a suitable means forattachment of a tubular graft to a stent member, but which avoid theproblems associated with such traditional devices as seen in FIG. 1.

For ease of understanding, FIGS. 2 through 9 herein depict variousembodiments of attachment of the first part to the second part. It willbe understood that the first part and/or the second part may extend toany desired length or shape. In the description below, the term “firstpart” is intended to include a generally tubular lumen through which afluid may flow, such as a graft and/or stent graft. The first part maybe made of any desired material, such as PTFE, ePTFE, Dacron, andcombinations thereof. The first part may be a tubular graft includingtwo opposed open ends, or it may include more than two open ends (forexample, a bifurcated or trifurcated graft having more than two openends). In the description below, the term “second part” is intended torefer to a means or mechanism that is secured to the first part, andthat aids in securing the device in the patient. In some embodiments,the term “second part” includes an expandable stent member, which may beself-expanding or may be expandable upon inflation of a balloon. Thedesired stent member may be made from any desired materials, includingmetallic and polymeric materials, and may include additional attachmentfeatures, such as barbs, hooks, and the like. The second part may have ageneral mesh design typically used in stents. In general, tubular graftsand stents are known and understood to those of skill in the art, andthe present invention provides safer, more secure ways to attach the twotogether to form a reduced diameter device upon implantation. Reductionin the diameter of devices upon implantation is beneficial to allow fora safer, more accurate and secure implantation of the device.

FIG. 2 depicts one embodiment of the present invention, providing adevice 100, which is capable of having a low profile when compressed. Aswith typical devices described above, the inventive device 100 includesa first part 110, which is a generally tubular, fluid flowable componenthaving an inner lumen 115. The first part 110 may be any size or lengthdesired, and typically will be selected to be substantially similar tothe body vessel into which the device 100 is being implanted. The firstpart 110 may be made from any desired biocompatible materials known tothose of ordinary skill in the art, including, for example, PTFE, ePTFE,Dacron, ultra high molecular weight polyethylene, and combinationsthereof. The first part 110 may be a stent-graft, if desired. The firstpart 110 may be tubular and have two opposed open ends defining astraight lumen, or it may be split, having more than two open ends(i.e., bifurcated, trifurcated, etc.). The number of open ends in thefirst part 110 is not critical, and any number may be selected. Forpurposes of the present invention, discussion will be made of only oneopen end of the first part 110, although it should be understood thatthe inventive attachment means may be disposed at any or all of the openends of the first part 110.

This embodiment includes a second part 120 at the end of the first part110. Preferred configurations for the second part include a stentmember, having a generally tubular, open mesh design. The second part120 may be approximately the same diameter as the first part 110 whenopened, or it may have a larger or smaller diameter. The second part 120may include any desired materials, including, for example metals (suchas nitinol), polymers, and combinations thereof. The second part 120 maybe self-expanding. In such embodiments, the second part 120 has anatural tendency to expand to its fully open state, which aids insecurement of the device 100 to the body lumen. Alternatively, thesecond part 120 may be expandable upon the exertion of force, such asthrough the use of an inflatable balloon or other opening means. Thesecond part 120 may have barbs or other components that aid insecurement of the device 100 to the body lumen, if desired. Further, thesecond part 120 may be any length desired, so as to effectively securethe device 100 in place after implantation.

In some embodiments, the first part 110 includes at least one inflatablechannel 125, which may be inflatable with a biocompatible material andused to aid in attachment of the device 100 to the body. The inflatablechannel 125 may, for example, be inflated such that it is pressedagainst the inside surface of the body lumen into which it is beingimplanted, thereby providing additional securement and/or sealing of thedevice 100 in place. The Figures set forth herein will each include oneinflatable channel 125, although it is understood that this feature isoptional and may be omitted, or alternatively that there may be morethan one inflatable channel 125.

In this first embodiment set forth in FIG. 2, the second part 120 may bejoined to the first part 110 by means of a reduced size attachment flap130. As with prior art devices, the reduced size attachment flap 130 isused to secure the second part 120 to the first part 110. The reducedsize attachment flap 130 is generally made of a polymeric material, andmay be made from the same material as the first part 110 if desired.Although FIG. 2 depicts the reduced size attachment flap 130 as aseparate piece from the first part 110, it will be understood that thereduced size attachment flap 130 may simply be the end of the first part110, without the need for a separate structure. For example, the reducedsize attachment flap 130 may be the end of the first part 110 foldedover itself to form a cuff. As another alternative, the flap 130 may behelically wound about the shape forming mandrel to form its structureSome exemplary methods of forming a tubular PTFE structure is describedin U.S. Pat. No. 7,125,464 and entitled “Methods and Apparatus forManufacturing an Endovascular Graft Section”; U.S. Pat. No. 7,090,693and entitled “Endovascular Graft Joint and Method of Manufacture”; andU.S. Pat. No. 6,776,604 and entitled “Method and Apparatus for ShapeForming Endovascular Graft Material”, all to Chobotov et al., thecomplete disclosures of which are incorporated herein by reference.Other means to secure the first part to the second part include the useof a tethered arrangement, which will be described in further detailbelow.

In contrast to prior devices, however, the reduced size attachment flap130 includes a series of discrete, separate ring members 135, whichcooperatively span the circumference of the first part 110, but are notconnected to each other. Each of these ring members 135 may be made froma solid material, and may be made from similar materials as the fullattachment ring typically used in such devices. Each of the ring members135 are desirably embedded in a polymeric material at the open end ofthe first part 110, thus ensuring securement of the ring members 135 tothe first part 110. The ring members 135 may have a general “V” shape,with the ends of the “V” disposed at the open end of the attachment flap130, although any shape may be used, such as a “U” or “W” shape.

The ring members 135 may include an elongated portion, which extendsbeyond the edge of the attachment flap 130, having an optionalsecurement member 140 at the end. It may be desired that the second part120 is directly secured to the first part 110 without the use of anoptional securement member 140. If used, the optional securement member140 may be used to secure the second part 120 to the ring members 135 inany desired means. In one embodiment, the optional securement member 140may be a general “dog-bone” type of securement, which is used to couplethe second part 120 to the ring members 135. The optional securementmember 140 may include any attachment design desired, including, forexample, eyelets, hooks, holes, snaps, “dog-bone” configurations, andcombinations thereof.

The reduced size attachment flap 130 is beneficial in that it providesan adequate and secure method of attaching a second part 120 (i.e., astent member) to the first part 110, while minimizing the amount of ringmaterial in the device 100. The reduced size attachment flap 130, withits discrete, separate ring members 135, includes a lesser amount ofsolid material and includes a greater amount of polymeric graftmaterial, and thus can be compressed to a greater degree than designsthat include a full ring spanning the entire circumference of the firstpart 110. As mentioned above, the present invention is capable ofcompressing the device to a compressed or rolled diameter of from about9 to about 15 French (about 3-5 mm), and more particularly from about 11to about 14 French.

In use, the second part 120 is secured to the first part 110 via thereduced size attachment flap 130. The device 100 may then be compressed(such as via rolling) to a smaller diameter. The compressed device 100may be fed into a catheter, and led through the body vessel to theimplantation site. The device 100 may then be released from the catheterat the site of implantation, and the second part 120 expanded to securethe device 100 in place. The first part 110 and second part 120 are heldtogether in a secure fashion by the reduced size attachment flap 130,ring members 135 and securement members 140.

In another embodiment, generally set forth in FIG. 3, a device 150including a first part 160 having a generally tubular shape with a lumen165 therethrough, as described above, and a second part 170, asdescribed above, is provided. As with above, the first part 160 may bemade from a biocompatible material, such as ePTFE, PTFE, Dacron, ultrahigh molecular weight polyethylene, and combinations thereof. As withabove, the second part 170 may be a tubular stent member, but mayinclude any desired attachment device desired. Further, the second part170 of this embodiment may be disposed at one or all open ends of thefirst part 160, as described above. In addition, the first part 160 mayinclude zero, one, or more than one inflatable channels disposed at oneor more ends, which may aid in providing attachment and sealing of thedevice 150 to the lumen into which it is implanted.

In this embodiment, as described above, the second part 170 is securedto the first part 160 at an attachment region 180. The attachment region180 may be a separate piece of material, or it may be integrally formedwith the first part 160. In some embodiments, the attachment region 180may simply be the end of the first part 160 or the attachment region 180may be the end of the first part 160 folded over itself to form a cuff.The attachment region 180 may be made from a polymeric material having adiscrete node and fibril structure, such as expanded PTFE. In thisembodiment, the second part 170 is secured to the first part 160 throughuse of a series of individual attachment members 185 having a hook-likefeature at one end thereof. The second part 170 may be directly securedto the first part 160, or may include an optional connector 175.Optional connector 175 may include any of the configurations describedabove (i.e., eyelet, hook, “dog-bone”, and the like).

Each of the attachment members 185 includes a securement feature at itsend, such as a hook, barb, or other latching feature, which may beembedded into the attachment region 180. In embodiments where theattachment region 180 is made from a material having a node and fibrilstructure, such as expanded PTFE, the attachment region 180 will includea series of nodes and fibrils. The securement feature of the attachmentmember 185 extends into the attachment region 180, where it may behooked onto one or more fibrils. Through attachment of the securementfeature to the fibrils, a secure connection may be made between thefirst part 160 and the second part 170.

As with the first embodiment, in use, the second part 170 is secured tothe first part 160 via the attachment region 180. The device 150 is thencompressed (such as via rolling) to a smaller diameter. The compresseddevice 150 may be fed into a catheter, and led through the body vesselto the implantation site. The device 150 may then be released from thecatheter at the site of implantation, and the second part 170 expandedto secure the device 150 in place.

FIG. 4 depicts yet another embodiment of the present invention, whichincludes an implantable device 200, including a first part 210 asdescribed above and a second part 220 (i.e., a stent) as describedabove. The first part 210 is a graft made from biocompatible materials,and generally includes a flowable lumen 215 extending therethrough.Optionally, the first part 210 may include one or more inflatablechannels 225, which may aid in providing attachment and sealing to thebody vessel into which the device 200 is implanted.

In this embodiment, the second part 220 is secured to the first part 210via a hybrid attachment region 230. The hybrid attachment region 230 ismade from a polymeric material, such as PTFE or expanded PTFE, and maybe integrally formed with the first part 210. In some embodiments, thehybrid attachment region 230 may be formed through folding the end ofthe first part 210 over itself to form a cuff. The hybrid attachmentregion 230 includes a reduced size ring 235, which spans thecircumference of the hybrid attachment region 230, but does not extendto the outer edge of the hybrid attachment region 230. The reduced sizering 235 is made from a material that has a tendency to expand radiallyoutward, and thus provides a means for maintaining the open end of thefirst part 210 in an open state. The reduced size ring 235 may be madefrom any desired material, including, for example, metals such asnitinol or polymeric materials. The reduced size ring 235 may include ageneral “W” shape and being sinusoidal in form. Notably, the reducedsize ring 235 is sufficiently small that it will not impede compressionof the device 200, but will be strong enough to aid in expansion of thedevice 200 when implanted.

In addition to the reduced size ring 235, the device 200 may alsoinclude a second part 220 including a series of individual attachmentmembers 240 at one end thereof. The second part 220 is secured to thefirst part 210 via the attachment members 240, as described previouslyin FIG. 3. Each of the attachment members 240 may include a securementfeature at its end, such as a hook, which is embedded into the hybridattachment region 230. In embodiments where the hybrid attachment region230 is made from a material having a node and fibril structure, such asexpanded PTFE, the hybrid attachment region 230 will include a series ofnodes and fibrils. The securement feature of the attachment member 240extends into the hybrid attachment region 230, where it may be hookedonto one or more fibrils. Through attachment of the securement featureat the end of the attachment member 240 to the fibrils, a secureconnection may be made between the first part 210 and the second part220.

In some embodiments, the reduced size ring 235 may not be used todirectly attach the second part 220 to the first part 210. Attachment ofthe second part 220 to the first part 210 may optionally be achievedthrough the use of securement features on the attachment members 240,which are secured in the hybrid attachment region 230. The reduced sizering 235 is present to aid in expansion of the device 200 andmaintaining the end of the first part 210 in an open state so as toallow fluid flow therethrough. In this embodiment, the reduced size ring235 contains less metal or other hard material than in traditionaldevice (such as that described in FIG. 1), and thus may be compressed toa smaller diameter than in traditional devices.

In some embodiments, instead of a securement via attachment members 240,the second part 220 may be secured to the first part 210 through the useof a hybrid attachment ring 230, with supported attachmentconfigurations, as will be described below.

FIGS. 5A and 5B depicts different embodiments of a device 250 using asupported attachment configuration for securement of a second part 255to a first part 260 including a tethered arrangement. The first part 260is described above, having a lumen 265 generally extending therethroughand may include an optional inflatable channel 266, as explained above.The second part 255 includes a general stent configuration describedabove. The configuration includes an attachment flap 270, also asdescribed above. The embodiment of FIG. 5A additionally depicts areinforced filament configuration, which may be useful in providing asecure, low profile design. In this embodiment, the attachment flap 270includes a series of reinforced attachment sites 275 secured byattachment tethers 280. There may be any number of attachment tethers280 and attachment sites 275 around the periphery of the attachment flap270. As can be seen, the second part 255 is directly secured to thefirst part 260. However, in some embodiments, the attachment sites 275may secure a plurality of optional securement members, which in turn,secures the second part 255. FIG. 5B depicts an embodiment in whichthere is no reinforced attachment site, but rather the tethers 280directly secure the second part 255 at securement site 276, such as byintertwining and/or interlacing the tether 280 and the second part 255,or using a looped configuration. Furthermore, the tethers 280 themselvesmay be intertwined and/or interlaced with one and the other or even justplaced over one and the other. For example, one portion of the tether280 may be laid over and/or under another portion the tether 280. Suchinterlacing in an under-and-over arrangement may take a form of a braidof portions of the tethers 280. The second part 255 may be directlyattached to the first part 260, however, in some embodiments, the secondpart 255 may be secured by using a general “dog-bone” or othersecurement configuration.

The attachment tethers 280 may be made of PTFE and/or ePTFE, or anyother material desired. The attachment tethers 280 may be formedintegrally with the first part 260, or they may be a separate featurethat is attached to the first part 260. As can be seen in FIGS. 5A-5B,each tether 280 is made of a first strand 280A and second strand 280B,which are each secured to either the reinforced attachment site 275 orsecurement site 276. The first strand 280A and second strand 280B may bea single unitary strand, forming the tether 280 such as by loopingthrough the attachment site 275. Alternatively, the first strand 280Aand second strand 280B may be separate pieces, which are separatelysecured to the attachment site 275 or securement site 276. The tether280 can include a single unitary piece whereby first strand 280A andsecond strand 280B are made from one single piece. If desired, theattachment sites 275 may be secured to the attachment tethers 280through the use of fluorinated ethylene propylene (FEP) dispersion,which may provide improved bonding. The device 250 may include alternatesecurement features such as eyelets at the attachment sites 275 orsecurement sites 276, such as that seen in FIG. 5A. In this embodiment,a tether 280 may directly secure the second part 255 through eyelets atthe attachment site 275. The eyelet may optionally be formed as anintegral part of the second part 255, if desired. That is, the end ofthe second part 255 in contact with the first part 260 or attachmentflap 270 may include a plurality of eyelets for securement of thetethers 280. For example, when the second part 255 is a stent, the endof the stent may include a plurality of eyelets configured to allowtethers to secure therein.

Alternative and/or additional securement methods include adhesives,heat, compression, welding, sintering, and combinations thereof. Weldingmay include circumferential, substantially circumferential and/orpartial circumferential weld lines (not shown) in the portions of theattachment flap 270 and/or in portions of the first part 260 across orpartially across portions of the tethers 280. Through the use of atethered arrangement, the tethers may provide an improved strength ofattachment of the second part. In particular, each attachment point mayprovide a strength of about 4 to about 10 pounds-force (lbf). Using aplurality of tethered arrangements will improve the strength bymultiplying the number of tethers by the individual strength (about 4-10lbf.).

It is to be understood that the device 250 may include a reduced sizeattachment flap 270 with supported ring members as described above inother embodiments, in addition to the tethered configuration. Forexample, it may be desired to include a design that includes a series ofseparate and discrete ring members for support, but use attachment sites275 and attachment tethers 280 for securing the second part (and viceversa).

FIG. 6A depicts yet another embodiment of the low profile device,including a supporting roll feature, which provides added strength andsecurity to the attachment. As with the previous embodiments, the device300 includes a first part 310, which is a generally tubular prostheticmaterial having a lumen 315 extending therethrough, and a second part320, which is designed to secure the device 300 in place uponimplantation. As with above, the second part 320 can be a stent, and maybe either self-expanding or expandable upon force, such as through useof an inflatable balloon. The securement of the second part 320 to thefirst part 310 in this embodiment is achieved through the use of aseries of attachment members 325, which may be part of a unitarystructure forming the second part 320. In some embodiments, the secondpart 320 is directly secured to the first part 310, however, in otherembodiments, the second part may have a plurality of optional securementfeatures 330 at a first end and a supported hook 335 at the second end.The attachment members 325 may be made from any material desired, suchas metals, polymers, and combinations thereof. The optional securementfeature 330, when present, may include any securement features describedabove, such as eyelets, hooks, “dog-bone” configurations, and the like.

The supported hook 335 secures the attachment member 325 to the firstpart 310, and may best be seen in FIG. 6B. The second end of theattachment member 325 includes a general hook-like configuration forminga supported hook 335. The first part 310 includes a generally tubularconfiguration about the circumference at one end, forming a supportingroll or lip 340. The supporting roll 340 may be made from the samematerial as the first part 310, including, for example, PTFE and/orePTFE, but has a slightly larger circumference than the rest of thefirst part 310. In some embodiments, the supporting roll 340 is aseparate part, which may be attached to the first part 310, oralternatively, the supporting roll 340 may be formed from the first part310, i.e., by rolling one end of the first part 310 over itself.Although the supporting roll 340 may be made from a polymeric material,in some embodiments, the supporting roll 340 also may be made frommetallic materials.

In use, the supported hook 335 is placed about the supporting roll 340,such that the supported hook 335 is secured in place by the supportingroll 340. In some embodiments, the supported hook 335 extends completelyaround the supporting roll 340, providing a secure and strong attachmentthereto. It is particularly desirable that the supporting roll 340 besufficiently strong so as to withstand pull of the supported hook 335without tearing or otherwise breaking.

FIG. 7 depicts a similar attachment embodiment to FIG. 6B, but insteadof a supporting roll, the first part 350 includes a series of reinforcedholes 360 at one end. In this embodiment, the end of the first part 350to be secured to a second part (not shown) includes a series ofreinforced holes 360. The reinforced holes 360 may be formed via anydesired method, and made be made from any desired materials, such aspolymeric or metallic materials. The reinforced holes 360 typically aresufficiently strong to withstand pulling without tearing or breaking. Inuse, a plurality of attachment members 370, each having a secured hook380, are placed through the plurality of reinforced holes 360, such thateach attachment member 370 is secured into one reinforced hole 360. Aswith the embodiments described above, a second part (i.e., a stent) issecured to the attachment members 370 via any attachment configurationdesired.

In some embodiments, instead of reinforced holes 360, the reinforcementmay be achieved through a series of reinforced tabs or similar features.The ultimate goal of this embodiment is to provide a series of discretepoints of attachment, which are strong enough to withstand tearing orripping of the first part 350 upon pulling of the attachment members370. In these embodiments, the use of a full attachment ring (such asthat described in FIG. 1 above) may be avoided, allowing the devices tobe compressed to a smaller diameter for insertion into a patient's body.

FIGS. 8A and 8B depict an attachment using a series of reinforcementtabs 400. In such an embodiment, the first part 390 includes, at aplurality of securement points, a series of reinforcement tabs 400. Thereinforcement tabs 400 may be disposed about the periphery of the firstpart 390, and there are, e.g., at least 5 reinforcement tabs 400 aboutthe first part 390. A reinforcement tab 400 may be present at eachlocation of attachment of the second part (not pictured) to the firstpart 390.

The reinforcement tabs 400 are designed to provide a high degree of tearresistance in the axial direction. As is understood by those of skill inthe art, securement of the second part to the first part 390 may be viahooks or any other securement means. However, if the second part ispulled in a direction away from the first part 390, there is a risk thatthe first part 390 may tear or rip. Reinforcement tabs 400 aid inproviding strength to the device, thus reducing the risk of tearing orripping the first part 390.

Reinforcement tabs 400 may be made from a polymeric material such as,expanded PTFE. As can best be seen in FIG. 8B, the reinforcement tab 400includes two different orientations of nodes and fibrils, so as toprovide a more secure attachment. In particular, the reinforcement tab400 includes a first section 410 and second section 420, which areseparated in approximately the middle of the reinforcement tab 400 alongan axis A. In use, the axis A will substantially be in alignment withthe axis of the first part 390. The first section 410 includes a seriesof nodes and fibrils that are oriented in a direction that is about 1°to about 60° offset from the axis A. The second section 420 includes aseries of nodes and fibrils that are oriented in a direction that isabout 1° to about 60° offset from the axis A, in the opposite directionas the nodes and fibrils of the first section 410. In another embodimentthe nodes and fibrils of the first section 410 are oriented about 20° toabout 50° offset from the axis A, such as about 30° offset from the axisA. Similarly, the nodes and fibrils of the second section 420 areoriented about 20° to about 50° offset from the axis A, such as about30° offset from the axis A (in the opposite direction from the nodes andfibrils of the first section 410). The angle of the nodes and fibrils inthe first section 410 is approximately the same as the angle of thenodes and fibrils in the second section 420, in the opposite direction,with the axis A separating each section 410, 420.

The resulting reinforcement tab 400, as seen in FIG. 8B, has a series ofnodes and fibrils in the first section 410 and the second section 420that are offset from the axis A in opposite directions at about the sameangle. The angles of each node and fibril orientation can be about 30°offset from the axis A, thus creating an angle between the nodes andfibrils of the first section 410 and the nodes and fibrils of the secondsection 420 of about 60° therebetween. The second part (not pictured)may be secured to the first part 390 at the reinforcement tabs 400, andmay be at a location near the axis A of the reinforcement tab 400. Inthis manner, the second part may pull in a direction away from the firstpart 390, without risk of tearing the first part 390.

The reinforcement tab 400 may be made as a separate piece, which maythen be secured to the first part 390 via any desired means, including,for example, lamination, adhesives, threading, and combinations thereof.The reinforcement tab 400 may be made as a single unitary piece, or itmay be made as separate pieces attached together. If the reinforcementtab 400 is made as a single unitary piece, it may be formed through atwo-stage stretching process, where the first section 410 is stretchedin a first direction and then the second section 420 is stretched in asecond direct, as described above. Alternatively, the reinforcement tab400 may be formed from two separate pieces, which are then attachedtogether, with the first piece forming the first section 410 and thesecond piece forming the second section 420. In this fashion, the twopieces can be stretched in their respective directions and then securedtogether to form the two-section reinforcement tab 400 through anydesired means, including, for example, lamination, adhesives, threadingand combinations thereof.

FIG. 9 depicts another embodiment of the present invention. A device 500using a supported attachment configuration for securement of a secondpart 510 to a first part 512 including a tethered arrangement. The firstpart 512 is for example a graft as described above, having a lumen 514generally extending therethrough and may include an optional inflatablechannel (not shown), as explained above. The second part 510 includes ageneral stent configuration described above. The configuration includesan eyelet 518 formed in lower apices 524 of the second part 510 withtethers 520 disposed through the eyelets 518. Although, as depicted inFIG. 9 each of the apices 524 has any eyelet 518, the present inventionis not so limited. The tethers 520 may be formed from any of theabove-described materials and may be secured by any of theabove-described techniques. The configuration further includes a portionof graft material 516 overlaying the apices 524, the eyelets 518 and atleast portions of the tethers 520. The graft material 516 may be graftmaterial from the interior surface of the graft lumen 514 or graftmaterial from an internal portion, typically from a layer or layers ofgraft material which are laminated to for the second part 510, foldedover the apices 524, the and eyelets 518 and the tethers 520. Althoughmultiple tethers 520 are depicted in FIG. 9, the present invention isnot so limited, and any suitable number of tethers, including just onetether, may be used. The portion of graft material 516 may be secured tothe first part 512, the apices 524, the eyelets 518 and/or portions ofthe tethers 520 by any of the above-described techniques. Further, theconfiguration may include a radiopaque portion 520 to aid invisualization during delivery. The radiopaque portion 520 may bedisposed at selected apices 524, including all apices 524 if desired.The radiopaque portion 520 may be disposed underneath the graft material516, as shown, or as a mark disposed on a portion of the second part 510not covered by graft material 516. The radiopaque portion 520 may be inthe form of a radiopaque marker.

Each of the embodiments described above may be implanted into a patientvia any desired method, including, for example, through use of aninsertion catheter. The device is first compressed to a smallerdiameter, such as via rolling, and inserted into the catheter where itis held in the compressed state until implantation. The catheter isinserted into the patient's body lumen, and the implantable device iswithdrawn from the catheter. The second part (i.e., the stent) isexpanded, thus securing the device in the body lumen.

If desired, the implantable devices herein may include a second part atonly one or at all open ends of the first part. For example, if thefirst part is a tubular graft, there may be a second part at both theproximal and the distal ends of the first part, using one or more of theattachment configurations described above. In addition, if the firstpart is a device including more than two open ends (i.e., a bifurcatedor trifurcated device), any or all of the open ends may include anattachment flap and second part, using one or more of the attachmentconfigurations described above. For example, the first open end of animplantable device may incorporate the attachment configuration of FIG.2, while a second open end of an implantable device may incorporate theattachment configuration of FIG. 7. Any combination of attachmentconfigurations described above may be used as desired.

The following embodiments or aspects of the invention may be combined inany fashion and combination and be within the scope of the presentinvention, as follows:

Embodiment 1

A device for implantation into a body lumen having a reducedimplantation diameter, comprising:

-   -   (a) a generally tubular first part having a lumen extending        therethrough for the flow of bodily fluid, said first part        including a first open end and a second open end; and    -   (b) a second part attached to said first open end of said first        part, wherein said second part is capable of securing said        device into a body lumen;    -   wherein said first open end comprises an attachment flap that is        compressible to a reduced diameter as compared to a device        incorporating a full attachment ring, and wherein said        attachment flap comprises a plurality of attachment sites        secured by a plurality of attachment tethers.

Embodiment 2

The device of embodiment 1, wherein said second part is secured to saidfirst part at said attachment sites.

Embodiment 3

The device of embodiment 1, wherein said attachment sites are secured tosaid attachment tethers through the use of FEP dispersion.

Embodiment 4

The device of embodiment 1, wherein said attachment sites are secured tosaid attachment tethers through heat compression, welding or sinteringprocesses.

Embodiment 5

The device of embodiment 1, wherein said attachment tethers comprisePTFE, ePTFE, and combinations thereof.

Embodiment 6

The device of embodiment 1, wherein each of said attachment sitescomprises an individual hole through said attachment flap.

Embodiment 7

The device of embodiment 1, wherein each of said attachment sitescomprises physical interlocking of said second part and said tether.

Embodiment 8

The device of embodiment 1, wherein said attachment tethers are securedto said second part through eyelets in said second part.

Embodiment 9

The device of embodiment 8, wherein material from interior portions ofthe first part is folded over the eyelets in said second part.

Embodiment 10

A method of manufacturing a tubular prosthesis for delivery into a bodylumen of a patient, comprising the steps of:

-   -   (a) providing a device for implantation into a body lumen having        a reduced implantation diameter, comprising:        -   (i) a generally tubular first part having a lumen extending            therethrough for the flow of bodily fluid, said first part            including a first open end and a second open end; and        -   (ii) a second part attached to said first open end of said            first part, wherein said second part is capable of securing            said device into a body lumen;        -   wherein said first open end comprises an attachment flap            that is compressible to a reduced diameter as compared to a            device incorporating a full attachment ring;    -   (b) providing a plurality of attachment sites comprising a        plurality of tethers at said attachment flap for securing said        first part and said second part to one and the other; and    -   (c) securing said first part and said second part to one and the        other at said plurality of attachment sites.

Embodiment 11

The method of embodiment 10, wherein said second part is secured to saidfirst part at said attachment sites.

Embodiment 12

The method of embodiment 10, wherein said attachment sites are securedto said attachment tethers through the use of FEP dispersion.

Embodiment 13

The method of embodiment 10, wherein said attachment tethers comprisePTFE, ePTFE, and combinations thereof.

Embodiment 14

The method of embodiment 10, wherein each of said attachment sitescomprises an individual hole through said attachment flap.

Embodiment 15

The method of embodiment 10, wherein each of said attachment sitescomprises physical interlocking of said second part and said tether.

Embodiment 16

The method of embodiment 10, wherein said attachment tethers are securedto said second part through eyelets in said second part.

Embodiment 17

The method of embodiment 10, wherein material from interior portions ofthe first part is folded over the eyelets in said second part.

Embodiment 18

A method of implanting a tubular prosthesis into a body lumen of apatient, comprising the steps of:

-   -   (a) providing a device for implantation into a body lumen having        a reduced implantation diameter, comprising:        -   (i) a generally tubular first part having a lumen extending            therethrough for the flow of bodily fluid, said first part            including a first open end and a second open end; and        -   (ii) a second part attached to said first open end of said            first part, wherein said second part is capable of securing            said device into a body lumen;        -   wherein said first open end comprises an attachment flap            that is compressible to a reduced diameter as compared to a            device incorporating a full attachment ring, and wherein            said attachment flap comprises a plurality of attachment            sites secured by a plurality of attachment tethers; and    -   (b) delivering the device to a desired location within the body        lumen.

The various embodiments described herein are useful in allowing for theimplantation of prosthetic devices into relatively narrow spaces (i.e.,body lumens) in a safer and more secure fashion. Allowing for thecompression of such devices to reduce the diameter of the device duringimplantation is an important and effective means to safely implantingsuch devices into patients' bodies.

While various embodiments of the present invention are specificallyillustrated and/or described herein, it will be appreciated thatmodifications and variations of the present invention may be effected bythose skilled in the art without departing from the spirit and intendedscope of the invention. For example, the reinforced holes and/or eyeletsmay have any suitable configuration for receiving attachment membersand/or tethers, including without limitation the size and configurationof holes or orifices of the reinforced holes and/or eyelets throughwhich the attachment members and/or tethers are disposed. Further, theshapes and sizes of the attachment members and/or tethers may be varied.Moreover, modifications of reinforcement tabs and/or graft materials forproviding reinforcement, including weld lines, are within the scope ofthe present invention. Still further, any of the embodiments or aspectsof the invention as described in the claims or in the specification maybe used with one and another without limitation.

What is claimed is:
 1. An endovascular device comprising: a stent havingapices at an end of the stent; a graft; and at least one tetherconnecting a corresponding one of the apices to a surface the graft, theat least one tether having opposite first and second ends, wherein aportion of the graft is folded over the corresponding one of the apicesand secured to the surface of the graft, and wherein the portion of thegraft covers the corresponding one of the apices and a portion of the atleast one tether so that the first and second ends of the at least onetether is exposed along the surface of the graft.
 2. The endovasculardevice of claim 1, wherein the surface of the graft is an exteriorsurface of the graft.
 3. The endovascular device of claim 2, wherein thegraft comprises a plurality of layers having one or more inner layersand one or more outer layers.
 4. The endovascular device of claim 3,wherein the portion of the graft folded over the corresponding one ofthe apices comprises at least one of the one or more inner layers. 5.The endovascular device of claim 1, wherein the corresponding one of theapices comprises an eyelet extending from the end of the stent.
 6. Theendovascular device of claim 5, wherein the at least one tether isdisposed through the eyelet.
 7. The endovascular device of claim 5,wherein the at least one tether comprises a plurality of tethers thatare disposed through the eyelet.
 8. The endovascular device of claim 7,wherein each of the tethers have opposite first and second ends, and theportion of the graft covers a portion of each of the tethers so that thefirst and second ends of each of the tethers are exposed along thesurface of the graft.
 9. The endovascular device of claim 1, wherein thestent is a balloon expandable stent.
 10. The endovascular device ofclaim 1, wherein the stent is a self-expandable stent.
 11. Anendovascular device comprising: a stent comprising peaks, valleys, andeyelets extending from ends of the valleys; a graft connected to thestent; and at least one tether disposed through a corresponding one ofthe eyelets, wherein a portion of the graft is folded over acorresponding one of the valleys and secured to a surface of the graftto cover the corresponding one of the apices.
 12. The endovasculardevice of claim 11, wherein the graft comprises a plurality of layershaving one or more inner layers and one or more outer layers.
 13. Theendovascular device of claim 12, wherein the portion of the graft foldedover the corresponding one of the apices comprises at least one of theone or more inner layers.
 14. The endovascular device of claim 11,wherein a through hole of the corresponding one of the eyelets is belowa concave portion of the corresponding one of the valleys.
 15. Theendovascular device of claim 14, wherein the at least one tethercomprises a plurality of tethers that are looped through the throughhole of the eyelet.
 16. The endovascular device of claim 15, wherein theportion of the graft is folded over the concave portion of thecorresponding one of the valleys.
 17. The endovascular device of claim15, wherein the portion of the graft covers a portion of each of thetethers.
 18. The endovascular device of claim 11, wherein the stent is aballoon expandable stent.
 19. The endovascular device of claim 11,wherein the stent is a self-expandable stent.
 20. A method ofmanufacturing an endovascular device comprising a stent having peaks,valleys, and eyelets extending from ends of the valleys, and a graftconnected to the stent, the method comprising: positioning the stent sothat a corresponding one of the eyelets overlaps with a surface of thegraft; looping at least one tether through a through hole of thecorresponding one of the eyelets; folding a portion of the graft over aconcave portion of a corresponding one of the valleys to cover thecorresponding one of the eyelets and a portion of the at least onetether; and securing the portion of the graft on the surface of thegraft.